# K071380: Modification to Solanas Posterior Stabilization System

- Pathway: 510(k) (Special)
- Applicant: Alphatec Spine, Inc.
- Decided: Aug 20, 2007 after 95 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K853033 (1985). 10 ancestors in all.
18 later devices descend from it; 5 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052201: Solanas Posterior Stabilization System, Alphatec Spine, Inc. (2005) Summary page 2.

## Most influential descendants
- K173522: Solanas® Posterior Stabilization System (2017), 5 descendants of its own
- K111076: Solanas Avalon Posterior Fixation System (2011), 5 descendants of its own
- K191185: Solanas® Posterior OCT Fixation System (2019), 4 descendants of its own
- K200936: Invictus™ CT Spinal Fixation System (2020), 3 descendants of its own
- K133214: Blackbird Spinal System (2014), 3 descendants of its own

## Recalls of this device
- Nov 1, 2010 · Not classified · Z-0932-2012: These lots were not manufactured correctly in that the instrument does not have the durability required to repeatedly perform over its full service life and, therefore, may experience breakage in the 
- Aug 5, 2009 · Not classified · Z-0502-2010: Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of th
- Aug 5, 2009 · Not classified · Z-0503-2010: Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of th

## Indications for use
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. Hook components are indicated for use at Cl-C7. Polyaxial screws are limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine. The components in the Solanas Posterior Stabilization System can be linked to the components in the Zodiac Polyaxial Spinal Fixation System offered by Alphatec Spine using the Axial Rod Connectors, Parallel Rod Connectors or Transitional Rods • Degenerative disk disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. • Spondylolisthesis • Spinal Stenosis • Fracture/Dislocation • Atlanto/Axial fracture with instability • Revision of previous cervical spine surgery • Tumors

Source page: https://510kreport.com/device/K071380
Methodology: https://510kreport.com/methodology